Catalog Number

MA1251_US

Brand Name

MAWI

Version/Model Number

MA1251

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

4963d43d-76cc-4005-82cd-4f4639cb7f82

Public Version Date

October 13, 2022

Public Version Number

4

DI Record Publish Date

June 07, 2021

Package DI Number

B353MA12512

Quantity per Package

25

Contains DI Package

B353MA12511

Package Discontinue Date

September 30, 2022

Package Status

Not in Commercial Distribution

Package Type

Small Box